Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

Trial Information

Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

This study concern the active control during 10 years of patient with latent prostate cancer
who accept not be treated immediately.

Inclusion Criteria:

- patient with a latent prostatic cancer

- aged less 75 years old,

- life expectation higher than 10 years

- Clinic statue T1c or T2a

- with a seric PSA (prostatic specific antigen)smaller than 10ng/ml

- more than 10 biopsy cores samples

- patient with less than 3 cores samples with tumor and none care sample with more than
3mm of tumor

- Gleason score inferior at 7

- patient's agreement about project and a second biopsy which will include definitive
patient: realized 3 months after the first and having: 14 biopsy cores samples (10
like previously and 4 more specific: taking around the positives initials biopsies),
less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor,
a Gleason score superior at 7.

Exclusion Criteria:

- patient aged 75 years old and more

- no patient's agreement

- lack of understanding of plan

- patient with guardianship

- life expectation smaller than 10 years

- patient with an other cancer less than 5 years

- Local clinical statue greater than T2a

- seric PSA higher than 10ng/ml

- less than 10 biopsies

- more than 2 positives biopsies during the first intervention

- 3 cores samples with more than 3mm of tumor

- 4th grade on the biopsies

- patient's refuse to realize the second biopsies

- patient who ask a treatment after the first medical examination

- patient with less 4 special biopsies around the previously initial cores samples or
more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient
having a 4 grade on biopsies, during the second medical examination.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluates specific survival to 10 years

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Nicolas MOTTET, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinique Mutualiste Chirurgicale

Authority:

France: Direction Générale de la Santé

Study ID:

0700043

NCT ID:

NCT00921258

Start Date:

December 2007

Completion Date:

July 2011

Related Keywords:

Prostate Cancer

latent prostate cancer

Patient with latent prostate cancer

PSA ≤ 10 ng/ml

Clinical stage T1c or T2a

Patient who accept just be control

Prostatic Neoplasms

Name

Location

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